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OTC ORAL ANTISEPTIC FINAL FORMULATION TESTING GUIDELINES PROPOSED BY FDA

This article was originally published in The Tan Sheet

Executive Summary

OTC ORAL ANTISEPTIC FINAL FORMULATION TESTING GUIDELINES PROPOSED BY FDA in a Feb. 9 tentative final monograph. The agency noted that it is offering procedures for testing the final formulations of such products because "final formulation of an oral antiseptic drug product can affect the effectiveness of the active ingredient." The guidelines, according to FDA, are based on the in vitro effectiveness testing procedures recommended by the OTC Oral Cavity Drag Products Review Panel and the testing procedures proposed by the agency in the OTC first aid antiseptic drugs tentative final monograph.
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